DMC Services
Data Monitoring Committee (DMC)
Independent DMC oversight supported by a 1500+ member network of experts
Advarra DMC services provide experienced, independent management and the expertise to oversee any therapeutic area.
Unmatched Expertise in DMC Oversight for 20+ Years
Advarra provides the resources and expertise to assemble, charter, and manage your DMC within any therapeutic area, anywhere on the globe. As a third-party services provider, our goal is to facilitate the safety oversight of trial participants, ensure security of patient data and integrity of clinical trial results, while working closely with your clinical trial team to adhere to country-specific regulations.
Timelines That Meet Trial Needs
From drafting the charter to contracting experts, Advarra DMC services have the fastest average time to kickoff in the industry so it won’t delay the start of your clinical trial. With our network of 1500+ independent, global experts, we can find and contract committee members from anywhere around the globe and in any therapeutic specialty as needed. Following each DMC review meeting, Advarra delivers written recommendations to sponsors within 1 business day.
Execution, Excellence, and Customer Satisfaction
Our dedicated staff of project managers are rigorously trained and adhere to strict standard operating procedures. By taking a proactive approach to communication, we address concerns early on and avoid surprises to minimize the chances of delays. All projects are staffed with both a lead DMC project manager and a backup, so that clinical trial teams can always reach someone when needed. This ensures the highest level of support and customer satisfaction.
Global Regulatory Compliance
Project Managers stay current on US FDA and EU EMA guidelines, as well as any applicable country-specific requirements, which help ensure objectivity and independence of all aspects of DMC oversight. In fact, none of the review boards administered by Advarra have ever been cited for a regulatory audit finding by a global regulatory body throughout our entire 20+ year history of managing DMCs.
Technology to Streamline Administration and Reporting
Advarra’s Safety Oversight Administration and Reporting (SOAR) Platform securely stores trial data, confidential DMC documents, and reports for your project. All activity is captured within a complete audit trail which complies with applicable regulations, including HIPAA, GDPR,PIPEDA and FDA Part 11.
Manager Spotlight
Barbara Schneider, PhD, MBA
Executive Director, Biostatistical Services
Dr. Barbara Schneider heads Advarra’s independent data monitoring committee and endpoint adjudication services, which have provided trusted safety oversight for clinical trials since 2002. Prior to joining Advarra, Dr. Schneider was the founder and CEO of Watermark Research Partners. Watermark was one of the first companies to provide independent data safety monitoring board (DSMB) services and endpoint adjudication to the clinical trial industry. (Watermark joined Advarra in 2021.)
James Riddle, MCSE, CIP, CPIA, CRQM
Senior Vice President, Global Review Operations
James Riddle brings 25+ years of experience providing support to the clinical research community and oversees all of Advarra’s global review services including IRB, IBC, DMC, EAC. In this role, he helps sponsors, CROs, and research sites advance clinical research with a mission to improve human health. His expertise includes developing and operationalizing processes for maximum efficiency, client satisfaction, and participant protection; development and implementation of technology solutions; and efficient, compliant operation of large clinical research review programs. Riddle is a regular speaker at industry events and has written abundantly on research compliance and efficiency topics. He is also a member of CTTI, NWABR, SASI, and PRIM&R.
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Frequently Asked Questions
Explore our comprehensive FAQ page for detailed answers to questions about our IRB, IBC, DMC, and EAC services.